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NCT01036009 · OUTCOME

Relapse at 2 Years Post-transplant.

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies · Source last updated 2016-06-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 years post transplant.

What was measured

Definition of relapse was \>5 % blasts in bone marrow

Groups in this outcome

Group I: Observation

Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.

Group II: Intervention

Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group I: Observation17
Group II: Intervention26

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I: Observation6Not reportedNot reportedNot reportedNot reported
Group II: Intervention4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      26
    units
    Participants
description
Definition of relapse was \>5 % blasts in bone marrow
groups
  1. description
    Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
    id
    OG000
    title
    Group I: Observation
  2. description
    Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
    id
    OG001
    title
    Group II: Intervention
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years post transplant.
title
Relapse at 2 Years Post-transplant.
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice